Impact of Improving Gastrointestinal Symptoms on Autism Symptoms and Oxidative Stress

NCT02442115 | Completed

• 1 other identifier: CCI-09-00212
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The clinical manifestation of autism spectrum disorder (ASD) is complex, with medical and mental health disruptions that occur with the three core behavioral criteria used for diagnosis (social behavior, communication, restricted interests/repetitive behavior). Co-occurring medical conditions, such as gastrointestinal dysfunction (GID), often are overlooked when designing research strategies to understand the mechanisms underlying the expression of ASD. This study was initially a collaboration between Children's Hospital Los Angeles (CHLA) and the Children's Hospital at Vanderbilt University. The current research project proposes to recruit subject at CHLA and the Center for Autism and Developmental Disorders (CAND), a Children's Hospital of Orange County and University of California Irvine (UCI) Health collaborative program. In Aim 1, the investigators will characterize GID in pediatric populations with ASD. Over a 12 month period, subjects will receive standard of care for their GID, typically functional constipation. The study population will be characterized with a standardized instrument for diagnosing functional GI disorders in children, the Questionnaire on Pediatric Gastrointestinal Symptoms, and with the clinical acumen of an experienced pediatric gastroenterologist. Nutritional information also will be collected to determine whether there are patterns of GIDs that correlate with dietary and nutritional status. The in-depth characterization and treatment of GIDs in children with ASD will provide a unique way of determining if ASD symptom and GID symptom improvement are related to each other. In Aim 2, the investigators will do in-depth assessment of each subjects functional status for social communication, emotional regulation, cognitive function, speech-language, sensory integration, and a biomarker of oxidative stress. The latter will be measured in urine samples over the course of one year. There are no direct interventions for autism symptoms in this study. Rather, subjects will receive standard of care for the GID diagnosis and secondary effects on ASD symptoms will be evaluated. Our power calculation shows that the investigators will be adequately powered with the proposed study design and recruitment targets. As part of the study, the investigators have developed a collaboration with investigators in the University of Southern California (USC) School of Engineering, in which the investigators will work with them to develop computational tools to assist in the characterization of videotaped Autism Diagnostic Observation Schedule (ADOS-2) assessments.

Conditions

Autistic Disorder; Constipation; Gastrointestinal Diseases

Keywords

Autism; Autism Spectrum Disorder (ASD); Tummy Troubles; Constipation; GI Disorders; Gastrointestinal Disorders; Gastrointestinal; Oxidative Stress; Stomach problems; Behaviors; Autistic; ASD; MET gene; GID; Pediatric; Pediatric GI disorders; Children with Autism; functional constipation

Outcome Measures

Primary Outcomes (2)

• Reduction in F2-IsoProstanes (IsoPs) oxidative stress biomarker

  1 year

• Reduction in T-score from Social Responsiveness Scale (SRS-2) (Teacher questionnaire)

  1 year

Study Arms (2)

ASD with GID

Children with Autism Spectrum Disorder with Functional Constipation will be treated with standard of care defined by NASPGHAN by a pediatric gastroenterologist, and evaluated at 4 visits over 1 year for their medical condition. These children will be enrolled in some ASD treatment program by their parents. The treatment program is not part of the current study. Measures of ASD symptoms will be done at each visit to determine social communication, emotional and cognitive improvement due to the FC treatment. Measures of F2-isoprostane, a marker of oxidative stress, will be done at each visit to determine if FC treatment and ASD symptom improvement relates to improvement in a child's physiology.

Other: Treatment of Functional Constipation by

ASD without GID

Children Autism Spectrum Disorder without Functional Constipation will be evaluated for their ASD symptoms at 4 times over 1 year. These children will be enrolled in some ASD treatment program by their parents. The treatment program is not part of the current study. Measures of F2-isoprostane, a marker of oxidative stress, will be done at each visit to determine if ASD symptom improvement relates to improvement in a child's physiology.

Interventions

Treatment of Functional Constipation by OTHER

The NASPGHAN protocol is used by pediatric gastroenterologist to treat functional constipation. Status is monitored at 4 visits and adjustments to treatment are made based on clinical standards and judgment.

Also known as: NASPGHAN standard of care

ASD with GID

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with Autism Spectrum Disorders with and without functional constipation

You may qualify if:

• English or Spanish-speaking of any ethnicity
• Boys or girls aged 5 years 0 months to 17 years 11 months
• A clinical diagnosis of functional constipation (FC) for the ASD+/FC+ group, with or without encopresis
• Clinical assessment of ASD using Diagnostic and Statistical Manual of Mental Disorders (DSM IV or V criteria)
• ADOS-validated diagnosis of ASD
• Gestational age between 36 and 42 weeks
• Birth weight of at least 2500 grams
• Children with suspected or an existing clinical diagnosis of ASD and FC will be recruited and consented for the study. Assessments and clinical diagnosis may be completed and confirmed through the Baseline study visit for subjects to be eligible.
• Teacher participation is not required for child participation. However, teacher participation will be requested around the time of child enrollment.

You may not qualify if:

• Severe sensory or motor impairments (deafness, blindness;
• Identified inherited metabolic, syndromic, or progressive neurological disorders (including epilepsy, Down Syndrome, Rett Syndrome, Tuberous Sclerosis, Neurofibromatosis, Fragile X Syndrome);
• A non-functional GID, such as ulcerative colitis, Celiac disease or Hirschsprung's disease;
• Failure to meet birth weight/gestational age as noted above
• Participation in another ASD research study at the same time
• Not enrolled in an ASD intervention program

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

The Center for Autism & Neurodevelopmental Disorders

Santa Ana, California, 92705, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine sample collection. Saliva sample collection for DNA extraction.

MeSH Terms

Conditions

Autistic Disorder; Constipation; Gastrointestinal Diseases; Autism Spectrum Disorder; Digestive System Diseases; Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pat Levitt, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Simms/Mann Chair in Developmental Neurogenetics, Institute for the Developing Mind

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: May 13, 2015
• Study Start: April 29, 2015
• Primary Completion: February 14, 2018
• Study Completion: February 6, 2019
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

US (2)